PATHFAST Myoglobin II reagent cartridge recall
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro…
Why was PATHFAST Myoglobin II reagent cartridge recalled?
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
- Product
- PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro…
- Recalling firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
- Quantity
- 272 KITS in total
- Distribution
- US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)